2024 Regulatory Policy Forum Takes an In-Depth Look Into the “Once in a Generation” Changes to the EU Pharmaceutical Legislation
Brussels — 4 December 2024 — DIA and the Regulatory Affairs Professionals Society (RAPS) just wrapped the 2024 Regulatory Policy Forum, a summit that convened 3-4 December 2024 at the Radisson Grand Place in Brussels. The event focused on two days of interactive discussions and idea exchange, bringing together key stakeholders across the medicinal products development lifecycle to address the potential critical challenges of transitioning to the new EU General Pharmaceutical Legislation framework.“RAPS and DIA are parts of an ecosystem of organizations whose approaches can be different, but whose missions are often aligned,” said Brian Savoie, Senior Vice President, Education & International Programs, Regulatory Affairs Professionals Society (RAPS). “We are pleased to see so many professionals come together for the vital multi-stakeholder conversations this forum provided.”
Held in an atmosphere of positive dialogue and collaboration, the Forum provided a platform to share insights on how to ensure a smooth transition to the new legislative landscape. Discussions centered on the need for strategic planning, change management, sufficient piloting of new approaches, and the development of robust guidance, expertise, and resources to enable effective operation from Day 1 of the new framework.
Sessions explored what it takes to implement a large piece of Legislation in the EU, lessons learned from previous regulation implementations, how to transition from one framework to the next, and the vision of various stakeholders on how to keep Europe competitive.
Reflecting on the Forum’s impact, Sara Torgal, Senior Scientific Programs Manager at DIA, stated, "this forum has been an invaluable opportunity to reflect on the lessons of the past and apply them to the challenges ahead. By learning from previous regulatory implementations, we can take thoughtful, proactive steps to ensure a smoother transition. Together, we are building a foundation for success in this critical legislative change."
The programme for the summit was carefully curated by a planning committee of experts across the pharmaceutical community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. The agenda consisted of 25 expert speakers across eight interactive sessions, showcasing the latest developments, opportunities, and critical issues in the sector.
Featured speakers included:
- Olga Solomon, Head of Unit B5 - Medicines: Policy, Authorisation and Monitoring, European Commission - DG SANTE
- Peter Arlett, Head Data Analytics and Methods Task Force, European Medicines Agency (EMA)
- Steffen Thirstrup, Chief Medical Officer, European Medicines Agency (EMA)
- Günter Waxenecker, Head, Austrian Agency for Health and Food Safety (AGES)
- Sabine Atzor, Head of EU Regulatory Policies, Roche and Co-Chair of EFPIA's Regulatory Strategy Committee
- Alexander Natz, Secretary General, EUCOPE
- Peter Bogaert, Partner, Covington & Burling
- Annette Bakker, President and Chair of the Board, Children's Tumor Foundation
To learn more about 2024 Regulatory Policy Forum, visit www.regpolicyforum.org.
ABOUT DIA
DIA is a leading global life science membership association that drives collaboration in drug, device, and diagnostics development in pursuit of a healthier world. Founded in 1964 with headquarters in Washington, D.C., and offices in Europe and Asia, DIA provides unparalleled networking opportunities, educational resources, scientific research publications, and professional development programs to members in more than 80 countries.
Learn more at DIAglobal.org, and connect with DIA on LinkedIn, Facebook, X (Twitter), and Instagram.
ABOUT REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. www.raps.org